GSK has reported positive results from part one of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial investigating the use of Jemperli (dostarlimab) to treat patients with endometrial cancer.
The trial investigated Jemperli plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by Jemperli alone and compared it to a group receiving chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer.
The trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in overall survival (OS) in the patient population.
The study also showed a clinically meaningful OS benefit in two specific patient subgroups: those with mismatch repair deficiency (dMMR)/microsatellite instability-high (MSI-H) and those with mismatch repair proficiency (MMRp)/microsatellite stability (MSS).
Dostarlimab is a monoclonal antibody that hinders the programmed cell death protein 1 (PD-1) receptor on some cells of the immune system to fight cancer.
GSK research and development senior vice president Hesham Abdullah said: “With today’s headline results from part one of the phase III RUBY trial, dostarlimab plus chemotherapy has become the only immuno-therapy combination to show a survival benefit in this broader patient population in this treatment setting. We look forward to sharing detailed results of this analysis with regulatory authorities and the larger scientific community.”
Full results from the trial analysis will be published in a medical journal and presented at an upcoming scientific meeting.
In 2021, the FDA gave Jemperli an accelerated approval for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
According to GSK’s Q2 2023 report, Jemperli achieved £25m ($30.3m) in sales in Q2 2023, driven by increasing new patient starts in the US. It is now available in 18 markets worldwide.
According to GlobalData, Jemperli is forecast to generate $1.4bn in 2029.
GlobalData is the parent company of Clinical Trials Arena.
